Chloramphenicol dosage and administration

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Chloramphenicol
CHLORAMPHENICOL SODIUM SUCCINATE® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

ADMINISTRATION

Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Administration of 50 mg/kg/day in divided doses will produce blood levels of the magnitude to which the majority of susceptible microorganisms will respond.

As soon as feasible an oral dosage form of chloramphenicol should be substituted for the IV form because adequate blood levels are achieved with chloramphenicol by mouth.

The following method of administration is recommended:

Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval. This is prepared by the addition of 10 mL of an aqueous diluent such as Water for Injection or 5% Dextrose Injection.

DOSAGE

Adults

Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals. In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible. Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly. (See discussion under Newborn Infants.) Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques.

Children

Dosage of 50 mg/kg/day divided into 4 doses at 6-hour intervals yields blood levels in the range effective against most susceptible organisms. Severe infections (e.g. bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired liver or kidney function may retain excessive amounts of the drug.

Newborn Infants

(See section titled “Gray Syndrome’’ under ADVERSE REACTIONS.) A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in blood and tissues adequate to control most infections for which the drug is indicated. Increased dosage in these individuals, demanded by severe infections, should be given only to maintain the blood concentration within a therapeutically effective range. After the first two weeks of life, full-term infants ordinarily may receive up to a total of 50 mg/kg/day equally divided into 4 doses at 6-hour intervals. These dosage recommendations are extremely important because blood concentration in all premature infants and full-term infants under two weeks of age differs from that of other infants. This difference is due to variations in the maturity of the metabolic functions of the liver and the kidneys.

When these functions are immature (or seriously impaired in adults), high concentrations of the drug are found which tend to increase with succeeding doses.

Infants and Children with Immune Metabolic Processes

In young infants and other children in whom immature metabolic functions are suspected, a dose of 25 mg/kg/day will usually produce therapeutic concentrations of the drug in the blood. In this group particularly, the concentration of the drug in the blood should be carefully followed by microtechniques.

References

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=aed29594-211d-49ef-813f-131975a8d0e3